PNE Effectiveness Cluster Trial



Status:Recruiting
Conditions:Back Pain, Back Pain, Chronic Pain, Chronic Pain, Orthopedic, Pain
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:7/28/2018
Start Date:May 24, 2017
End Date:May 1, 2019
Contact:elizabeth lane, DPT
Email:elizabeth.lane@utah.edu
Phone:2517143199

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The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain

This is a cluster randomized trial that involves training regions of physical therapy clinics
to use pain neuroscience education or continue with usual care. The investigators will
examine outcomes for patients with chronic neck or back pain.

Chronic spinal pain is a very common and costly condition. An estimated 26.4% of Americans
have experienced an episode low back pain (LBP) and 13.8% have experienced neck pain in the
past 3 months. Lifetime prevalence of spinal pain ranges from 54% to 80% and the estimated
healthcare costs for those with spinal pain are 57% higher than those without. While many
with acute LBP have a favorable prognosis, those who develop chronic pain continue will
experience persistent poor health and place a large burden on the healthcare system.

With growing healthcare costs and mounting disability, there is increased demand for physical
therapists to promote more effective self-management strategies for patients with chronic
spinal pain. Education is a critical component of self-management. Pain neuroscience
education (PNE) is an education method used by physical therapists to help patients
understand the biology, physiology and psychological factors influencing their pain
experience and to reconcile faulty cognitions and beliefs associated with persistent pain and
disability8. PNE has been shown to have positive effects on patient-reported outcomes for a
variety of spinal pain conditions. This study will examine the impact of widespread
implementation of PNE into routine physical therapy care.

The proposed mechanism of PNE is proposed to relate changes in patients' conceptualization of
the pain experience, specifically concepts associated with fear, knowledge, and beliefs of
pain. Additional research has identified autonomous motivation and self-efficacy as relevant
to patients' behavioral responses to pain. Autonomous motivation is proposed to be an
essential factor for behavior change, adhering to a treatment program and persistent positive
health behavior changes. Autonomous motivation has not been examined as an influencing factor
in the PNE model. Self-efficacy relates to the degree an individual feels they have control
over their situation; and high self-efficacy has been associated with more active coping
efforts. This study will examine self-efficacy and autonomous motivation as potential
mediators of the ability of a PNE intervention improve functional outcomes in a pragmatic
clinical environment.

This project's overall goal is to determine the effectiveness of providing physical
therapists with PNE training on patient-centered outcomes (physical function and pain
interference) for patients with chronic neck or back pain receiving physical therapy.
Secondarily, the investigators will explore mechanisms of effects of PNE by examining the
role of autonomous motivation and self-efficacy. To accomplish these goals, the investigators
will conduct a cluster-randomized clinical trial, randomly assigning groups of clinics to
receive PNE training or usual care with no additional training for physical therapists
working in the clinic. This design allows for maximum external validity and generalizability
across outpatient physical therapy clinics.

Primary Aims I. Compare effectiveness of PNE training vs. no additional training for physical
therapists on patient-centered outcomes (physical function and pain interference) for
patients with chronic spinal pain. The investigators hypothesize patients receiving treatment
from physical therapists receiving PNE education will show greater improvement in
patient-centered outcomes.

Secondary Aims I. Compare the effects of PNE training vs. no additional training for physical
therapists on the patient-physical therapist alliance. The investigators hypothesize patients
receiving treatment from physical therapists receiving PNE education will show greater
alliance with their physical therapist.

II. Explore the mediating effects of autonomous motivation and self-efficacy on
patient-centered outcomes. The investigators hypothesize autonomous motivation and/or
self-efficacy will mediate the effects of education on patient-centered outcomes.

Inclusion Criteria:

- Age 18-75 at time of first physical therapy session

- Primary reason for physical therapy is low back and/or neck pain

- Meets the NIH definition of chronic pain (i.e., neck or back pain on at least half the
days in the past 6 months.)

Exclusion Criteria:

- No spinal surgery within the previous 12 months

- No evidence of "red flag" conditions (e.g., cauda equine syndrome, cancer, fracture,
infection or systemic disease) that requires immediate referral from physical therapy
to medical care

- Not currently known to be pregnant
We found this trial at
28
sites
842 North Highland Avenue Northeast
Atlanta, Georgia 30306
Phone: 251-714-3199
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3450 Cobb Parkway Northwest
Acworth, Georgia 30101
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5815 Windward Parkway
Alpharetta, Georgia 30005
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1025 East-West Connector
Austell, Georgia 30106
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153 Narrows Parkway
Birmingham, Alabama 35242
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1453 Riverstone Parkway
Canton, Georgia 30114
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909 South Park Street
Carrollton, Georgia 30117
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626 East Main Street
Cartersville, Georgia 30121
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Columbus, Georgia 31909
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8492 Hiram Acworth Highway
Dallas, Georgia 30157
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2097 North Decatur Road
Decatur, Georgia 30033
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5500 Chamblee Dunwoody Road
Dunwoody, Georgia 30338
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2600 County Road 58
Helena, Alabama 35080
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45 Enterprise Path
Hiram, Georgia 30141
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1713 Montgomery Highway
Hoover, Alabama 35244
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744 Noah Drive
Jasper, Georgia 30143
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Kennesaw, Georgia 30144
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455 Philip Boulevard
Lawrenceville, Georgia 30046
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400 Tower Road
Marietta, Georgia 30060
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2846 Moody Parkway
Moody, Alabama 35004
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Newnan, Georgia 30265
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151 Wisdom Road
Peachtree City, Georgia 30269
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277 Georgia 74
Peachtree City, Georgia 30269
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5009 Riverchase Drive
Phenix City, Alabama 36867
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540 West Crossville Road
Roswell, Georgia 30075
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4600 West Village Lane
Smyrna, Georgia 30080
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3455 Peachtree Parkway
Suwanee, Georgia 30024
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4404 Hugh Howell Road
Tucker, Georgia 30084
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